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Senior Quality Assurance Engineer

Kelly Services

Cambridge, MA
Job Code:
  • Engineering
Kelly Services
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Job Details

Job Title Senior Quality Assurance Engineer

Jobid US588YAR_BH1433421

Location: Cambridge, MA, 02238, USA

Description **Senior Quality Assurance Engineer**

**Description of the position**

The Sr. Quality Assurance Engineer will lead Post Market quality-related activities for existing devices by providing support and guidance in the analysis and investigation of product and quality systems issues, and will lead New Product Development QA activities through oversight of the Design Control process. Primary responsibilities for this position include management of CAPA and nonconformity investigations, oversight of design process, including engineering change requests and other design control documentation, updating risk management files, supporting health hazard assessments and recalls, internal and supplier auditing, and conducting GMP and other training as needed.

The Sr. Quality Assurance Engineer will have a solid knowledge of, and the ability to provide support and drive quality system improvements in compliance with medical device quality system regulations and standards (FDA Quality System Regulation, ISO 13485).

This position requires frequent communication and coordination with staff in the headquarters office in France.

**Primary Responsiblities**

The Sr. Quality Assurance Engineer will provide strong leadership and guidance to cross-functional failure investigation teams in order to ensure effective management of the CAPA and nonconformity (NCR) processes. The specialist will have the knowledge and experience to evaluate and monitor current processes and procedures and make improvements as needed to maintain process effectiveness and regulatory compliance.

+ Work with Quality Assurance and other functional teams to support the CAPA and NCR processes. Initiate and support processing and closure of CAPAs and NCRs related to product performance and compliance. Provide leadership and guidance to investigation team members to drive the timely completion of CAPAs and NCRs.
+ Perform all product investigation-related activities, including product containment, root cause analysis, corrective action determination and planning, implementation management, effectiveness check determination and closure.
+ Evaluate CAPA/NCR metrics and implement improved parameters or methods as needed in order to provide management with effective tracking data.
+ Participate with Medical team in Health Hazard Assessments for any potential product recalls / field corrections; support any removal/correction activities.
+ Update risk management files to incorporate post market findings related to product safety and performance.
+ Represent Quality Systems functions during internal, regulatory and 3rd party audits.
+ Perform all aspects of Supplier Quality Management, including supplier evaluation, auditing and providing guidance throughout the evaluation/purchasing process.
+ Participate in implementation of Enterprise Quality Management System, including drafting SOPs, Work Instructions and training of users.
The Sr. Quality Assurance Engineer will work cross-functionally with Project Management, Operations and Subject Matter Experts to support the Design Control process.

+ Provide quality oversight of product development tasks and documentation required to satisfy design controls and risk management in accordance with established SOPs.
+ Provide quality and compliance guidance in all phases of the Design Control process, from project start through design transfer.
+ Review and approve Verification and Validation documentation and processes.
+ Review and approve Risk Management documents.
+ Work with SMEs to develop Design History Files, Device Master Records and Device History Records.
+ Review and approve Engineering Change Requests.
+ Participate in Design Review meetings.
+ Oversee Design Transfer activities.
+ Perform internal and supplier quality audits; promote audit readiness.
+ Provide training on Quality processes, GMP and other compliance-related topics as required.
+ Maintain awareness of new/updated regulations and standards related to Medical Device quality.
Qualifications and Experience

+ Minimum Bachelors Degree in science or engineering is required.
+ Significant experience working in a regulate industry (Medical Device, IVD, Pharma) is required (Medical Device strongly preferred)
+ The Senior Quality Assurance Engineer must be adept at working in a team environment and must be able to communicate clearly across all disciplines, including Engineering, Operations, Medical/Clinical, Project Management, Sales/Marketing, Customer Service and QA/Ra.
+ Solid expertise in design controls, risk management and auditing, and investigations including root-cause analysis is required.
+ Working knowledge of Software Medical Device Design and Development including agile design methodology, and associated regulations (e.g.IEC 62304) is preferred.
+ Proven ability to lead multiple tasks and projects, to work independently and with team members at all levels, and to lead change initiatives
+ In-depth knowledge of ISO 13485 and 14971, 21 CFR 820, cGMP's
+ Experience in FDA inspections preferred.
+ Fluid written and verbal communication skills
+ Proficiency in MS Office tools including Word, Excel, PowerPoint
+ Experience working with enterprise quality management systems (EQMS) is a plus
+ Quality auditing certification is desired but not required.
**Why Kelly** **®** **?**

Kelly puts you in charge of your career, with access to cutting edge projects and technologies inindustry leading organizations. Top companies throughout the world have trusted Kelly as a premiersource of engineering talent and services since 1965. And engineering job seekers know Kelly as a firmwith an unmatched reputation for quality, integrity and professionalism. Whether you seek the varietyand flexibility of working on short term project engagements, or prefer contract-to-hire or directhire placement with our clients, apply with Kelly to explore opportunities that suit your specificprofessional interests.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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